There is a recognized and compelling need for the rapid and accurate diagnosis of common infectious diseases in an out-patient setting. This need results from a rapidly emerging trend toward what is sometimes referred to as “patient centric care” in which convenience—along with better health outcomes and low cost—becomes a key market driver.
The field of in vitro diagnostics is well established, with many manufacturers and a wide spectrum of products and technologies. The testing for infectious pathogens in human patient specimens is largely confined to centralized laboratory testing in Clinical Laboratory Improvement Amendment (CLIA) rated medium-complexity or high-complexity facilities. Commonplace techniques used in such laboratories include traditional culturing of specimens, immunological assaying using Enzyme-Linked Immunosorbent Assay (ELISA), nucleic acid testing (such as polymerase chain reaction, PCR), and other methods.
Many different types of devices can be used to complete diagnostic processes in centralized laboratories. It has been historically difficult, however, to complete such diagnostic processes entirely, or almost-entirely in an outpatient setting where equipment and materials that are common-place in a laboratory may not be readily available or are suitable for use. As a result, relatively few devices are readily available that are able to complete diagnostic processes in the field (meaning outside of a laboratory environment) without access to the resources of a laboratory.